Multilayer balloons

ABSTRACT

An example medical device includes a balloon that is inflatable to an inflated configuration. The balloon includes a non-compliant layer coextruded on an inner layer, and an outer layer coextruded on the non-compliant layer. The non-compliant layer is configured to delaminate from the inner and the outer layers in the inflated configuration. The non-compliant layer may be configured to rupture in the inflated configuration. An example technique includes inflating the balloon to a predetermined pressure sufficient to rupture the non-compliant layer and insufficient to rupture both the inner and outer layers. The example technique further includes deflating the balloon, and introducing the balloon into a vasculature. Another example technique includes coextruding a non-compliant layer on an inner layer, coextruding an outer layer on the non-compliant layer, and forming a balloon from the inner layer, the non-compliant layer, and the outer layer.

TECHNICAL FIELD

This disclosure relates to medical devices including balloons.

BACKGROUND

Catheters may be used in intravascular procedures or other procedures tofacilitate minimally invasive access to a target site. For example, anangioplasty catheter may include balloons mounted to the catheter thatmay be advanced to the target site and inflated to clear or compress ablockage, for example a stenosis. As another example, a stent deliverycatheter may include a stent positioned over a balloon, which may beinflated to deploy the stent.

SUMMARY

Example medical devices include multilayer balloons are describedherein. In some examples, a multilayer balloon includes nested balloons,and may have a higher burst pressure than a single layer or single wallballoon having a wall thickness equivalent to the combined wallthickness of the multilayer balloon. Arranging, nesting, and inflatingballoons to form multilayer balloons with uniform inflationcharacteristics may be relatively difficult or inefficient. Some exampletechniques according to the disclosure allow manufacturing a multilayerballoon from a single extrusion.

Clause 1: In some examples, a medical device includes a ballooninflatable to an inflated configuration. The balloon includes anon-compliant layer coextruded on an inner layer, and an outer layercoextruded on the non-compliant layer. The non-compliant layer isconfigured to delaminate from the inner and the outer layers in theinflated configuration.

Clause 2: In some examples of the medical device of clause 1, thenon-compliant layer is configured to delaminate from the inner layerbefore delaminating from the outer layer.

Clause 3: In some examples of the medical device of clause 1, thenon-compliant layer is configured to delaminate from the outer layerbefore delaminating from the inner layer.

Clause 4: In some examples of the medical device of any of clauses 1 to3, the inner layer and the outer layers are more flexible than thenon-compliant layer.

Clause 5: In some examples of the medical device of any of clauses 1 to4, the non-compliant layer is configured to rupture in the inflatedconfiguration at a predetermined pressure, wherein the predeterminedpressure is insufficient to rupture both the inner and the outer layers.

Clause 6: In some examples of the medical device of clause 5, thenon-compliant layer is configured to rupture after delamination of thenon-compliant layer from the inner and outer layers.

Clause 7: In some examples of the medical device of clause 5, thenon-compliant layer is configured to fragment in the inflatedconfiguration at the predetermined pressure.

Clause 8: In some examples of the medical device of clause 7, an innersurface defined by the outer layer is configured to contact an outersurface defined by the inner layer in the inflated configuration.

Clause 9: In some examples of the medical device of clause 8, the innerlayer defines an inner balloon and the outer layer defines an outerballoon, the inner balloon being nested in the outer balloon.

Clause 10: In some examples of the medical device of clause 9, the innerballoon is fluidically isolated from the outer balloon.

Clause 11: In some examples of the medical device of any of clauses 1 to10, the non-compliant layer has a greater stiffness than each of theinner layer and the outer layer.

Clause 12: In some examples of the medical device of any of clauses 1 to11, the non-compliant layer includes a thermoplastic.

Clause 13: In some examples of the medical device of clause 12, thethermoplastic includes a high-density polyethylene (HDPE).

Clause 14: In some examples of the medical device of any of clauses 1 to13, one or both of the inner layer and the outer layer includes athermoplastic elastomer.

Clause 15: In some examples of the medical device of clause 14, thethermoplastic elastomer includes a polyether block amide (PEBA).

Clause 16: In some examples of the medical device of any of clauses 1 to15, the non-compliant layer is coextensive with one or both of the innerlayer and the outer layer.

Clause 17: In some examples of the medical device of any of clauses 1 to16, the non-compliant layer defines at least one of a discontinuity, aperforation, a window, or an opening in the inflated configuration.

Clause 18: In some examples, a system includes the medical device of anyof clauses 1 to 17 and a second medical device secured to the balloon.

Clause 19: In some examples of the system of clause 18, the secondmedical device includes a stent crimped to the balloon.

Clause 20: In some examples, a system includes the medical device of anyof clauses 1 to 17, and further includes an elongated member. Theballoon is mounted to the elongated member. The elongated memberincludes a catheter body.

Clause 21: In some examples, a medical device includes a ballooninflatable to an inflated configuration. The balloon includes anon-compliant layer coextruded on an inner layer, and an outer layercoextruded on the non-compliant layer. The non-compliant layer isconfigured to rupture in the inflated configuration at a predeterminedpressure. The predetermined pressure is insufficient to rupture both theinner and the outer layers.

Clause 22: In some examples of the medical device of clause 21, thenon-compliant layer is configured to delaminate from the inner and theouter layers before the rupture.

Clause 23: In some examples of the medical device of clause 21 or clause22, the non-compliant layer has a greater stiffness than each of theinner layer and the outer layer.

Clause 24: In some examples of the medical device of any of clauses 21to 23, the balloon is in the inflated configuration at the predeterminedpressure, and the non-compliant layer is ruptured such that thenon-compliant layer defines a plurality of perforations.

Clause 25: In some examples of the medical device of any of clauses 21to 23, the balloon is in the inflated configuration at the predeterminedpressure, and the non-compliant is substantially disintegrated such thatan inner surface defined by the outer layer substantially uniformlycontacts an outer surface defined by the inner layer.

Clause 26: In some examples of the medical device of any of clauses 21to 23, the non-compliant layer defines at least one of a discontinuity,a perforation, a window, or an opening in the inflated configuration.

Clause 27: In some examples, a method includes inflating a balloon to apredetermined pressure. The balloon includes a non-compliant layercoextruded on an inner layer and an outer layer coextruded on thenon-compliant layer. The predetermined pressure is sufficient to rupturethe non-compliant layer and insufficient to rupture both the inner andthe outer layers. The method includes deflating the balloon, andintroducing the balloon into vasculature of a patient.

Clause 28: In some examples of the method of clause 27, inflating theballoon at the predetermined pressure includes causing only thenon-compliant layer to rupture to cause an inner surface defined by theouter layer to contact an outer surface defined by the inner layer.

Clause 29: In some examples of the method of clause 27, inflating theballoon at the predetermined pressure includes causing only thenon-compliant layer to rupture to cause the non-compliant layer todefine at least one of a discontinuity, a perforation, a window, or anopening in the inflated configuration.

Clause 30: In some examples, the method of any of clauses 27 to 29further includes, after introducing the balloon into the vasculature,pressurizing the balloon to an operational pressure.

Clause 31: In some examples, a method includes inflating a balloon to apredetermined pressure. The balloon includes a non-compliant layercoextruded on an inner layer and an outer layer coextruded on thenon-compliant layer. The predetermined pressure is sufficient todelaminate the non-compliant layer from the inner and the outer layers.The method includes deflating the balloon, and introducing the ballooninto vasculature of a patient.

Clause 32: In some examples, the method of clause 31 further includes,after introducing the balloon into the vasculature, pressurizing theballoon to an operational pressure.

Clause 33: In some examples, a method includes coextruding anon-compliant layer on an inner layer, coextruding an outer layer on thenon-compliant layer, and forming a balloon from the inner layer, thenon-compliant layer, and the outer layer. The non-compliant layer isconfigured to delaminate from the inner and the outer layers in aninflated configuration of the balloon.

Clause 34: In some examples of the method of clause 33, co-extruding thenon-compliant layer on the inner layer and coextruding the outer layeron the non-compliant layer includes coextruding a tubing including theinner layer, the non-compliant layer, and the outer layer.

Clause 35: In some examples of the method of clause 33 or clause 34, theforming the balloon includes molding the inner layer, the non-compliantlayer, and the outer layer over a scaffold.

Clause 36: In some examples, the method of any of clauses 33 to 35further includes heat-setting the balloon.

Clause 37: In some examples, the method of any of clauses 33 to 36further includes inflating the balloon to a predetermined pressuresufficient to rupture the non-compliant layer, the predeterminedpressure is insufficient to rupture both the inner and the outer layers.

Clause 38: In some examples, the method of clause 37 further includesallowing only the non-compliant layer to fragment at the predeterminedpressure to cause an inner surface defined by the outer layer to contactan outer surface defined by the inner layer.

Clause 39: In some examples, the method of any of clauses 33 to 38further includes securing a second medical device to the balloon.

Clause 40: In some examples, the method of clause 39 includes securingthe second medical device to the balloon includes crimping a stent tothe balloon.

Clause 41: In some examples, the method of any of clauses 33 to 40further includes mounting the balloon to an elongated member.

Clause 42: In some examples, a method includes coextruding anon-compliant layer on an inner layer, coextruding an outer layer on thenon-compliant layer, and forming a balloon from the inner layer, thenon-compliant layer, and the outer layer. Only the non-compliant layeris configured to rupture in an inflated configuration of the balloon ata predetermined pressure.

Clause 43: In some examples of the method of clause 42, co-extruding thenon-compliant layer on the inner layer and coextruding the outer layeron the non-compliant layer includes coextruding a tubing including theinner layer, the non-compliant layer, and the outer layer.

Clause 44: In some examples of the method of clause 42 or clause 43, theforming the balloon includes molding the inner layer, the non-compliantlayer, and the outer layer over a scaffold.

Clause 45: In some examples, the method of any of clauses 42 to 44further includes heat-setting the balloon.

Clause 46: In some examples, the method of any of clauses 42 to 45further includes inflating the balloon to the predetermined pressure todelaminate the non-compliant layer from the inner and the outer layers.

Clause 47: In some examples, the method of any of clauses 42 to 46further includes securing a second medical device to the balloon.

Clause 48: In some examples of the method of clause 47, securing thesecond medical device to the balloon includes crimping a stent to theballoon.

Clause 49: In some examples, the method of any of clauses 42 to 48further includes mounting the balloon to an elongated member.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic and conceptual side view of an example medicaldevice including an elongated member and a balloon.

FIG. 2 is a schematic and conceptual partial side view of the examplemedical device of FIG. 1 further including a second medical devicesecured to the balloon.

FIG. 3A is a schematic and conceptual cross-sectional view of theballoon of FIG. 1 in a partly inflated configuration, where thecross-section is taken in a direction orthogonal to a longitudinal axisof the medical device.

FIG. 3B is a schematic and conceptual expanded view of thecross-sectional view of the balloon shown in FIG. 3A with the balloon inan inflated delaminated configuration.

FIG. 3C is a schematic and conceptual cross-sectional view of theballoon of FIG. 3A including a middle layer of the balloon in aninflated perforated configuration.

FIG. 3D is a schematic and conceptual cross-sectional view of theballoon of FIG. 3A with an inner layer of the balloon contacting anouter layer of the balloon.

FIG. 4 is a flowchart illustrating an example technique for using anexample balloon in a procedure.

FIG. 5 is a flowchart illustrating an example technique for preparing anexample balloon.

DETAILED DESCRIPTION

In examples described herein, a multilayer balloon configured to expandfrom a deflated configuration to an inflated configuration includes atleast three layers. An example multilayer balloon may be prepared bycoextrusion, for example, a trilayer extrusion. The inner and outerlayers of the multilayer balloon may include materials having the samecomposition or having different compositions. The middle layer mayinclude a material that has poor adhesion properties to the inner andouter layers, thus causing delamination of the middle layer from theinner and outer layers and the separation of the inner and outer layersfrom each other. The delamination could be activated during theextrusion of the multilayer balloon, for example, when the extrusion isunder a relatively high stress, or after the extrusion.

In some examples, the middle layer may be a relatively non-compliantlayer that exhibits perforation or partial or complete rupture duringinflation, so that the inner and outer layer may contact each other atone or more regions, or substantially contact across a major area of theinner layer, the outer layer, or the balloon following rupture ordisintegration of the middle layer. A relatively compliant layer (alsocalled a compliant layer herein) is a layer including a material thatinflates, deflates or deforms without resulting in mechanical failure ofthe material. A relatively non-compliant layer (also called anon-compliant layer herein) is a layer including a material that resistsinflation or deformation (relative to a compliant layer), for example,resulting in mechanical failure of the material in response to inflationor deformation beyond a predetermined threshold.

One or both of the delamination and the rupture of the middle layer mayresult in a multilayer balloon that includes inner and outer layerscapable of independent movement, similar to the behavior of multilayerballoons formed by nesting structurally distinct balloons. However, oneof the drawbacks to nesting multiple balloons may be that traditionalnesting balloons require additional manufacturing steps such as aligningrespective nested balloons to form the nested structure. The nestingstep may also result in the introduction of air or fluid pockets betweenadjacent balloon surfaces, needing additional manufacturing steps forremoval of fluid pockets to provide uniform inflation of the balloon.Example techniques and multilayer balloons according to the disclosuremay provide a nested balloon configuration obtained from a singlecoextrusion, without requiring a nesting step for nesting separateballoons. Coextruding a single construction that results in a nestedballoon configuration may thus be easier to manufacture compared tonesting individual balloons into a nested configuration. Thus, exampletechniques according to the disclosure may be used to prepare multilayerballoons including nested inner and outer layers.

FIG. 1 is a schematic and conceptual side view of an example medicaldevice 10 including an elongated member 12 and a balloon 14 mountedcloser to a distal tip 16 of elongated member 12 than a proximal end ofelongate member 12. A hub 18 connected to the proximal end of elongatedmember 12 may allow elongated member 12 to be manipulated, advanced, orretracted, and may provide ports for communicating with lumens definedby elongated member 12. For example, hub 18 may include an inflation arm20 that may be connected to a source of inflating fluid to deliverinflating fluid through an inflation lumen port 22 to inflate balloon14, or deflate balloon 14 by withdrawing the inflating fluid. In someexamples, hub 18 may include an adapter 24 to receive a guidewirethrough a guidewire lumen in elongated member 12 (not shown). In someexamples, elongated member 12 may include a catheter body, for example,a balloon catheter, and hub 18 may include a catheter hub. In someexamples, instead of a guidewire catheter, medical device 10 may includea rapid-exchange balloon catheter system.

Elongated member 12 may be advanced to a target site, for example,through a body lumen such as a blood vessel of a patient. In someexamples, distal tip 16 may be introduced into the vasculature of thepatient through an incision or opening, followed by a shaft of elongatedmember 12. Elongated member 12 may be advanced through the body lumen,for example, over a guidewire introduced through adapter 24 of hub 18.Balloon 14 may be maintained in an uninflated or partly inflatedconfiguration while advancing elongated member 12 through thevasculature. When elongated member 12 is sufficiently advanced, forexample, such that balloon 14 is adjacent the target site, inflatingfluid may be delivered through inflation lumen port 22 to inflateballoon 14 to an inflated configuration at the target site. Balloon 14is illustrated in an inflated configuration in FIG. 1. In some examples,inflation of balloon 14 may result in expansion of the vasculature, orremoval of blockage, for example, clots, debris, or fat at the targetsite. The inflating fluid may subsequently be withdrawn throughinflation lumen port 22 to result in deflation of balloon 14, anddeflated balloon 14 may be withdrawn through the vasculature byretracting elongated member 12.

In some examples, balloon 14 may include one or more radiopaque markers17. For example, radiopaque marker 17 may include one or more radiopaquebands disposed about balloon 14, such as one marker 17 adjacent theproximal end of balloon 14 and another marker 17 adjacent a distal endof balloon 14, as shown in FIG. 1. Radiopaque marker 17 may allowballoon 14 to be observed using suitable radioimaging techniques duringa medical procedure, for example, while advancing or retracting balloon14 with elongated member 12.

In some examples, medical device 10 may include a second medical device26. FIG. 2 is a schematic and conceptual partial side view of medicaldevice 10 of FIG. 1 further including second medical device 26positioned over (e.g., co-axial with) balloon 14, and, in some examples,secured to balloon 14. In some examples, as illustrated in FIG. 2,second medical device 26 may include a stent crimped to balloon 14.Balloon 14 is illustrated in an uninflated configuration in FIG. 2, withthe stent in an unexpanded configuration ready for deployment. Inexamples in which second medical device 26 is secured to balloon 14,second medical device 26 may be advanced with balloon 14 to the targetsite, and the inflation of balloon 14 may trigger deployment of secondmedical device 26. For example, in examples in which second medicaldevice 26 includes a stent, inflation of balloon 14 may expand the stentto an expanded state to scaffold a region of the vasculature adjacentthe stent. In examples in which second medical device 26 was secured toballoon 14, after deploying second medical device 26 at a target sitewithin the patient and subsequently partially or fully deflating balloon14, second medical device 26 may remain in a deployed configuration atthe target site, and only balloon 14 can be withdrawn from the patient.In other examples, second medical device 26 may be withdrawn withballoon 14 after balloon 14 is partly or completely deflated.

Balloon 14 may be defined by a balloon wall 15. Balloon wall 15 includesmultiple layers, such that balloon 14 is a multilayer balloon. Balloon14 and balloon wall 15 are further described with reference to FIGS.3A-3D, which illustrate schematic and cross-sectional views of balloon14 in different configurations, the cross-section being taken in adirection orthogonal to a longitudinal axis of elongated member 12 (FIG.1). FIG. 3A is a schematic and conceptual cross-sectional view ofballoon 14 a, which is similar to balloon 14 of FIG. 1, in a partlyinflated configuration. Balloon wall 15 includes outer layer 32 andinner layer 36. In some examples, outer layer 32 defines an outermostsurface of balloon 14 a, while inner layer 36 defines an innermostsurface of balloon 14 a. However, in some examples, balloon 14 a mayinclude one or more additional layers. In addition, in some examples,one or more coatings or surface treatments may be applied to outer layer32, such as, but not limited to, a lubricious coating, a lubricioussurface treatment or a therapeutic agent. Outer layer 32 and inner layer36 may be formed of an inflatable material, for example, a polymercomposition. In some examples, outer layer 32 and inner layer 36 mayhave the same composition. In some examples, outer layer 32 and innerlayer 36 may have different compositions.

In some examples, balloon 14 a includes at least one middle layer 34disposed between outer layer 32 and inner layer 36, as shown in FIG. 3A.In some examples, middle layer 34 is formed of a material configured tohave relatively poor adhesion to or relatively easy delamination fromone or both of outer layer 32 and inner layer 36. In some examples,middle layer 34 may be coextensive with one or both of inner layer 36and outer layer 32. In some examples, middle layer 34 may define atleast one of a discontinuity, a perforation, a window, or another suchopening, such that outer layer 32 and inner layer 36 may contact eachother directly through the opening. In some examples, the discontinuity,the perforation, the window, or the opening may form in middle layer 34as a result of expansion or inflation of middle layer 34. In someexamples, middle layer 34 may define the discontinuity, the perforation,the window, or the opening before expansion or inflation. For example,middle layer 34 may be coextruded with one or both of inner layer 36 andouter layer 32 such that middle layer 34 defines the discontinuity, theperforation, the window, or the opening.

The layers of balloon 14 a may be formed from any suitable materialsthat provide the properties described herein. In some examples, one ormore of outer layer 32, middle layer 34, and inner layer 36 may includeone or more of acrylonitrile-butadiene styrene (ABS), polyamides, forexample, nylons, polyamide 6 (PA 6), or polyamide 66 (PA 66),polycarbonates (PC), polyethylenes (for example, high densitypolyethylenes (HDPE) or low density polyethylenes (LDPE)), poly(methylmethacrylate) (PMMA), polyoxymethylene (POM), polypropylenes (PP),polystyrenes (PS), polybutylene terephthalate (PBT), styreneacrylonitrile resin (SAN), thermoplastic elastomers (TPE) (for example,polyether block amides (PEBAs)), polyphenylene sulfide (PPS),polyetheretherketones (PEEK), polyurethanes, polyesters, or blends,copolymers, or coextrusions thereof. For example, one or more of outerlayer 32, middle layer 34, and inner layer 36 may include sublayers, forexample, coextruded layers. In some examples, the TPEs (or PEBAs) mayinclude materials sold under the PEBAX® brand name (Arkema, Paris,France) or VESTAMID (Evonik Industries, Essen, Germany).

TABLE 1 Material ABS PA 6 PA 66 PC HDPE LDPE PMMA POM PP PS PBT SAN TPEPPS ABS P P P P PA 6 P P P PA 66 P P P P PC P P P P P HDPE P P P P P P PP P P P LDPE P P P P P P P P P P PMMA P P P POM P P P P PP P P P P P P PP P P PS P P P P P P P P P PBT P P P P SAN P P P P TPE P P P PPS

In some examples, middle layer 34 may include a material selected tohave relatively poor adhesion to outer layer 32 and inner layer 36. Pooradhesion may be evaluated using a polymer welding compatibility matrixas a guide. In some examples, pairs of materials that form bad weldingjoints, fail to form a welding joint, or otherwise poorly adhere to eachother may be potential pair materials (“P”) as indicated by TABLE 1. Oneof a respective potential pair (for example, TPE and HDPE) may beselected for middle layer 34 and the other of the respective potentialpair may be selected for one or both of outer layer 32 and inner layer36. For example, both outer layer 32 and inner layer 36 may include aTPE such as a PEBA, for example, PEBAX® 7033 or 7233, and middle layer34 may include a thermoplastic, for example, an HDPE, so that middlelayer 34 has poor adhesion with outer layer 32 and inner layer 36.

While in the examples shown in FIGS. 3A-3D, balloons 14 a, 14 b, 14 c,and 14 d are illustrated having a circular cross-section, in someexamples, balloons 14, 14 b, 14 c, and 14 d may have any suitable shape,configuration, or cross-section. In some examples, balloon 14 may have ageometrically similar shape in an uninflated and an inflatedconfiguration. For example, balloon 14 may be cylindrical in bothuninflated and inflated configurations. In some examples, balloon 14 mayhave different shapes in uninflated and inflated configurations. Forexample, balloon 14 may be folded or otherwise have a compact uninflatedconfiguration.

While in the examples shown in FIGS. 3A-3D, balloons 14 a, 14 b, 14 c,and 14 d are illustrated as having two or three layers, in someexamples, balloons 14 a, 14 b, 14 c, and 14 d may have any number ofadditional layers, and the number of layers may change after one or moreof delamination, perforation, rupture, or disintegration of balloon 14or part of balloon 14. In some examples, one or more tie layers may beprovided between adjacent layers of balloon 14. For example, a tie layermay include an adhesive to promote adhesion of adjacent layers. In someexamples, one or more lubricant layers may be provided between adjacentlayers of balloon 14. For example, the lubricant layer may include alubricant to reduce adhesion between adjacent layers. In some examples,the lubricant may include one or more of silicone, graphene, or agraphitic coating. Providing a lubricant layer may promote delaminationby reducing a joining compatibility between layers adjacent thelubricant layer.

In some examples, middle layer 34 may include a non-compliant layer. Anon-compliant layer may be a layer that has lower flexibility, lowersoftness, higher rigidity, or compliance to expansion or inflationcompared to a compliant layer. A compliant layer, for example, a layerincluding a PEBA, may exhibit stretching in response to an inflationarypressure. In contrast, a non-compliant layer, for example, a layerincluding an HDPE, may exhibit reduced or relatively no stretchingcompared to a compliant layer. Whether a layer is compliant ornon-compliant may depend on the composition, hardness, and dimensions,for example, thickness, of the layer. Compliance may be measured, forexample, by measuring radial expansion of a layer as a ratio ofinflation pressure. In some examples, a compliant layer may exhibit anexpansion greater than about 10 millimeters/atmospheres (mm/atm), orgreater than about 20 millimeters/atmospheres, or greater than about 50millimeters/atmospheres. In some examples, a non-compliant layer mayexhibit an expansion lower than about 0.02 mm/atm, or lower than about0.01 mm/atm, or lower than about 0.001 mm/atm. A semi-compliant layermay exhibit an expansion greater than about 0.02 mm/atm and less thanabout 10 mm/atm. In some examples, middle layer 34 may include asemi-compliant layer.

In some examples, outer layer 32 may have a thickness between about0.005 millimeters (mm) and about 0.10 mm, for example, for coronaryballoon applications. The total thickness of balloon 14 may be higherfor non-coronary balloon applications, for example, up to 1 mm. In someexamples, middle layer 34 may have a thickness between about 0.001 mmand about 0.10 mm. In some examples, inner layer 36 may have a thicknessbetween about 0.005 and about 0.10 mm. In some examples, one or more ofouter layer 32, middle layer 34, or outer layer 36 may have a hardnessbetween about 25 Shore D and about 75 Shore D.

The hardness of respective layers of balloon 14 may vary. For example,the hardness of respective layers may increase from an outermost layerto an innermost layer of balloon 14. In some examples, the hardness ofrespective layers may decrease from an outermost layer to an innermostlayer of balloon 14. For example, outer layer 32 may be softer thanmiddle layer 34 to facilitate printing of patterns, instructions, ortext, or to facilitate securing or crimping of second medical device 26to balloon 14. In some examples, the hardness of a respective middlelayer or layers may be higher than the hardness of respective inner andouter layer or layers. In some examples, an inner layer or layers mayhave substantially the same hardness as an outer layer or layers ofballoon 14. In some examples, outer layer 32 and inner layer 36 may eachbe more flexible than middle layer 34. Thus, in examples in which middlelayer 34 includes a non-compliant layer, the non-compliant layer mayhave a greater stiffness than each of inner layer 36 and outer layer 32.Middle layer 34 may be softer, more flexible, or both softer and moreflexible than outer layer 32 and inner layer 36 to provide apredetermined softness to balloon 14.

In some examples, a compliance of a layer of balloon 14 may be reducedby adding components, for example, reinforcing material or fibers thatresist stretching or inflation. For example, one or more of outer layer32, middle layer 34, and inner layer 36 may include one or morereinforcing components, materials, or fibers. In some examples, thereinforcing components may include one or more of glass, metal, alloy,carbon, or polymers.

In some examples, middle layer 34 may be configured to delaminate fromouter layer 32 and inner layer 36 in an inflated configuration ofballoon 14 a, for example, a fully inflated configuration of balloon 14a. In some examples, middle layer 34 may delaminate from outer layer 32and inner layer 36 when balloon 14 a is inflated to a predetermineddelamination pressure. For example, middle layer 34 may have relativelylow welding or joining compatibility with one or both of outer layer 32and inner layer 36 such that middle layer 34 may separate from one orboth of outer layer 32 and inner layer 36 as balloon 14 a is inflated tothe predetermined pressure to result in delamination. In some examples,the predetermined pressure may be between about 0.1 atmospheres (atm)and 45 atm. While inflating may result in delamination, in someexamples, middle layer 34 may separate from one or both of outer layer32 and inner layer 36 in an uninflated configuration of balloon 14 a(for example, without inflation or prior to inflation) to result indelamination. FIG. 3B is a schematic and conceptual expanded view of thecross-sectional view of an example balloon 14 b similar to balloon 14 ashown in FIG. 3A in an inflated delaminated configuration. In thedelaminated configuration illustrated in FIG. 3B, a balloon wall 15 b ofballoon 14 b includes middle layer 34 delaminated from outer layer 32and inner layer 36. For example, delamination may be a state in which aninner surface 32 b of outer layer 32 is separated from an outer surface34 a of middle layer 34, and an outer surface 36 a of inner layer 36 isseparated from an inner surface 34 b of middle layer 34.

In some examples, inner surface 32 b of outer layer 32 and outer surface34 a of middle layer 34 may define a first inter-layer void 35 a, andouter surface 36 a of inner layer 36 and inner surface 34 b of middlelayer 34 may define a second inter-layer void 35 b. One or both of firstand second inter-layer voids 35 a or 35 b may exhibit a vacuum or apressure lower than a pressure within an interior volume defined byinner layer 36. In some examples, rupture or perforation of middle layer34 may cause first and second inter-layer voids 35 a or 35 b to befluidically connected. In some examples, debris or material originatingfrom rupture or perforation of middle layer 34 may occupy one or both offirst and second inter-layer voids 35 a or 35 b.

While the layers are illustrated as being physically separated withintermediate spacing in the example illustrated in FIG. 3B, in someexamples, the layers may be substantially in contact (e.g., in contactalong only some parts of the layers or along the entire adjacentsurfaces) in the delaminated configuration. For example, thedelamination may entail loss of adhesion between respective surfaces ofrespective layers, while still maintaining or being succeeded by contactbetween the respective surfaces of respective layers. In some examples,delamination of middle layer 34 from outer layer 32 and inner layer 36may result from relatively poor weld, adhesion, or joining compatibilitybetween pairs of respective materials of outer layer 32 and middle layer34, and inner layer 36 and middle layer 34, as indicated by poorcompatibility of potential pair materials in TABLE 1.

Outer layer 32, middle layer 34, and inner layer 36 may be capable ofindependent movement, for example, expansion or contraction, in thedelaminated configuration. For example, one or both of outer layer 32 orinner layer 36 may be capable of independent movement relative to middlelayer 34, or one or both of middle layer 34 or inner layer 36 may becapable of independent movement relative to outer layer 32, or even oneor both of middle layer 34 or outer layer 32 may be capable ofindependent movement relative to inner layer 36. Thus, in some examplesof the delaminated configuration illustrated in FIG. 3B, balloon 14 bmay behave similar to a nested series of balloons formed from a firstballoon including outer layer 32, a second balloon including middlelayer 34, and a third balloon including inner layer 36. For example, thefirst, second, and third balloons may be fluidically isolated from eachother. A balloon wall of a predetermined thickness including fluidicallyisolated nested balloons may exhibit better puncture resistance androbustness compared to a balloon wall including a single layer or alaminated multilayer having the same thickness. For example, a puncturein an outer surface of a single layer or laminated multilayer balloonmay propagate to an inner surface across the balloon wall, leading toballoon failure. In contrast, a puncture in an outermost balloon of aseries of fluidically isolated nested balloons may not propagate to aninnermost balloon, such that even if an outermost balloon is punctured,at least one unpunctured innermost layer will remain inflated.

In some examples, middle layer 34 includes the non-compliant layer.Balloon 14 a may thus include non-compliant middle layer 34 coextrudedon inner layer 36, and outer layer 32 coextruded on middle layer 34.Non-compliant middle layer 34 may be configured to delaminate from outerlayer 32 and inner layer 36 in an inflated configuration of balloon 14a. In some examples, non-compliant middle layer 34 may be configured todelaminate from inner layer 36 before delaminating from outer layer 32.For example, the joining compatibility of the pair of materials ofnon-compliant middle layer 34 and of inner layer 36 may be lower thanthe joining compatibility of the pair of materials of non-compliantmiddle layer 34 and outer layer 32. In other examples, non-compliantmiddle layer 34 may be configured to delaminate from outer layer 32before delaminating from inner layer 36. For example, the joiningcompatibility of the pair of materials of non-compliant middle layer 34and of outer layer 32 may be lower than the joining compatibility of thepair of materials of non-compliant middle layer 34 and inner layer 36.Thus, middle layer 34 may promote delamination of one or more layers ofballoon 14. In some examples, balloon 14 may include additional layersthat promote delamination. For example, balloon 14 may include more thanone layer that promotes delamination, for example, non-compliant layersor lubricant layers, to further improve delamination of predeterminedlayers of balloon 14.

In examples in which middle layer 34 includes a non-compliant layer,inflating balloon 14 a beyond a predetermined pressure may cause middlelayer 34 to perforate, or partly or completely rupture, while outerlayer 32 and inner layer 36 remain intact and act to maintain balloon 14a in an inflated or inflatable state. For example, FIG. 3C is aschematic and conceptual cross-sectional view of an example balloon 14 csimilar to balloon 14 a of FIG. 3A including middle layer 34 in aninflated perforated configuration. In some examples, a balloon wall 15 cof balloon 14 c includes middle layer 34 defining a plurality ofperforations 34 c. In some examples, when balloon 14 a of FIG. 3A isinflated to a predetermined pressure, middle layer 34 at least partlyruptures or perforates, forming balloon 14 c shown in FIG. 3C. Whileinner surface 32 b of outer layer 32 is shown spaced from outer surface36 a of inner layer 36, in some examples, inner surface 32 b of outerlayer 32 may contact outer surface 36 a of inner layer 36 at least atregions defined by perforations 34 c, i.e., outer layer 32 and innerlayer 36 may contact each other through the open spaces defined byperforations 34 c, for example, through first or second inter-layervoids 35 a or 35 b. In some examples, as shown in FIGS. 3B and 3C, firstand second inter-layer voids 35 a and 35 b of balloon 14 b may combineto form a combined inter-layer void 35 of balloon 14 c after rupture orperforation of middle layer 34, and perforations 34 c may extend throughcombined inter-layer void 35.

In examples in which middle layer 34 includes a non-compliant layer, thenon-compliant layer is configured to rupture in the inflatedconfiguration at a predetermined pressure. The predetermined pressure isinsufficient to rupture both inner layer 36 and outer layer 32, therebymaintaining balloon 14 a in an inflated or inflatable state. In someexamples, the non-compliant layer may be configured to rupture afterdelamination of the non-compliant layer from inner layer 36 and outerlayer 32. In some examples, the non-compliant layer may be configured tofragment in the inflated configuration at the predetermined pressure.

In some examples, inflating balloon 14 a to the predetermined pressuresufficient to cause one or both of delamination and rupture may beperformed as part of a technique for manufacturing balloon 14 a, asdescribed with reference to some example techniques according to thedisclosure, for example, techniques described with reference to FIGS. 4and 5. In addition to, or instead of delaminating during themanufacturing stage, in some examples, inflating balloon 14 a to thepredetermined pressure sufficient to cause one or both of delaminationand rupture may be performed by a medical practitioner while usingmedical device 10, as described with reference to some exampletechniques according to the disclosure, for example, techniquesdescribed with reference to FIGS. 4 and 5. In some examples, afterinflating balloon 14 a to the predetermined pressure, balloon 14 a maybe deflated to allow folding or otherwise compacting balloon 14 a tofacilitate packaging and use.

In some examples, the perforations, rupture, or tears in middle layer 34may cause middle layer 34 to substantially disintegrate in an inflatedconfiguration of balloon 14 a, so that middle layer 34 no longerseparates outer layer 32 and inner layer 36. For example, FIG. 3D is aschematic and conceptual cross-sectional view of an example balloon 14 dsimilar to balloon 14 a of FIG. 3A with inner layer 36 directlycontacting outer layer 32. For example, a balloon wall 15 d of balloon14 d may include inner surface 32 b defined by outer layer 32substantially uniformly (e.g., uniformly or nearly uniformly) contactingouter surface 36 a defined by inner layer 36 in the inflatedconfiguration of balloon 14 d. Outer layer 32 and inner layer 36 may becapable of independent movement, for example, expansion or contraction,in the inflated configuration shown in FIG. 3D. Thus, in the inflatedconfiguration illustrated in FIG. 3D, balloon 14 d may behave similar toa nested pair of balloons formed from a first balloon including outerlayer 32, and a second balloon including inner layer 36. For example,inner layer 36 may define an inner balloon, and outer layer 32 maydefine an outer balloon, with the inner balloon being nested in theouter balloon. In some examples, the inner balloon may be fluidicallyisolated from the outer balloon. For example, a loss of pressure orincrease in pressure in one of the inner or the outer balloons may notaffect the pressure in the other of the inner or the outer balloons. Ifsecond medical device 26, for example, a stent, punctures the outerballoon, at least an inner balloon may still remain pressurized,maintaining balloon 14 d inflated. Similarly, if the outer balloonpunctures as a result of contact with a calcified lesion or anotherrigid structure within a body lumen, at least an inner balloon may stillremain pressurized, maintaining balloon 14 d inflated.

Each of the delaminated configuration of balloon 14 d shown in FIG. 3Dand the inflated configurations of balloons 14 c and 14 d respectivelyshown in FIGS. 3C and 3D may exhibit higher burst or puncture resistancecompared to a single layer balloon having the same respective effectivewall thickness as respective balloon walls 15 b, 15 c, and 15 d. Forexample, a puncture in an outer surface of a single layer or laminatedmultilayer balloon may propagate to an inner surface across the balloonwall, leading to balloon failure. In contrast, the first, second, andthird layers may form nested balloons that are fluidically isolated fromeach other, preventing a loss of pressure in an outermost balloon fromresulting in a loss of pressure in an innermost balloon. A puncture inan outermost balloon of a series of fluidically isolated nested balloonsmay not propagate to an innermost balloon, such that even if anoutermost balloon is punctured, at least one unpunctured innermost layerwill remain inflated, maintaining the structural integrity and functionof the balloon. Thus, example multilayer balloons according to thedisclosure may be used in procedures where robustness andpuncture-resistance of balloons is desired.

FIG. 4 is a flowchart illustrating an example technique for usingballoon 14 in a procedure. As discussed with reference to FIGS. 3A-3D,in some examples, balloons 14 a-14 d may include middle layer 34including a non-compliant layer coextruded on inner layer 36, and outerlayer 32 coextruded on the non-compliant layer. While the exampletechnique of FIG. 4 is described with reference to balloon 14 shown inFIG. 1, balloons 14 a-14 d shown in FIGS. 3A-3D may be representative ofdifferent configurations of balloon 14 of FIG. 1, for example, duringperforming the example technique of FIG. 4. The example technique ofFIG. 4 optionally includes inflating balloon 14 to the predeterminedpressure sufficient to rupture the non-compliant layer, and insufficientto rupture both inner layer 36 and outer layer 32 (40). As discussedbelow, inflating balloon 14 to the predetermined pressure (40) may notbe required if inflating balloon 14 to an operational pressure wouldresult in rupture of the non-compliant layer or middle layer 34 withoutrupturing both inner layer 36 and outer layer 32. For example, theoperational pressure may be greater than or equal to the predeterminedpressure, and inflating to the operational pressure may therefore resultin rupture of the non-compliant layer, without requiring a separateinflating of balloon 14 to the predetermined pressure.

Inflating balloon 14 may include delivering inflating fluid to balloon14 through inflation lumen port 22 causing balloon 14 to expand to aninflated ruptured configuration, for example, the configuration ofballoon 14 c shown in FIG. 3C, in which middle layer 34 is at leastpartly perforated or ruptured, or the configuration of balloon 14 dshown in FIG. 3D, in which middle layer 34 is substantially ruptured ordisintegrated. In some examples, inflating balloon 14 to thepredetermined pressure (40) may result in delamination of one or both ofouter layer 32 from middle layer 34 or of middle layer 34 from innerlayer 36. For example, outer layer 32 may delaminate from middle layer34, or middle layer 34 may delaminate from inner layer 36, during theinflating, as shown in FIG. 3B (40). In some examples, at least partialdelamination may occur before the rupture of middle layer 34. Forexample, at least a portion of one of outer layer 32, middle layer 34,and inner layer 36 may separate from a portion of another of outer layer32, middle layer 34, and inner layer 36, before the rupture of anyportion of middle layer 34. In some examples, complete delamination mayoccur before the rupture of middle layer 34. For example, outer layer 32may completely delaminate from middle layer 34, and middle layer 34 maycompletely delaminate from inner layer 36, before the rupture of anyportion of middle layer 34. In other examples, delamination may be atleast partly concurrent in time with rupture during the inflating (40).For example, at least a portion of one of outer layer 32, middle layer34, and inner layer 36 may separate from a portion of another of outerlayer 32, middle layer 34, and inner layer 36 during rupture of aportion of middle layer 34.

In some examples, inflating balloon 14 to the predetermined pressure(40) may be performed before initiating a medical procedure, forexample, after removing balloon 14 from a medical package, or whileballoon 14 is in the medical package. In addition, or instead, inflatingballoon 14 to the predetermined pressure (40) may be performed duringmanufacture of balloon 14, for example, during or after coextrudingouter layer 32, middle layer 34, and inner layer 36 so that balloon 14is in a configuration similar to that of balloon 14 c or balloon 14 d inthe medical package.

In some examples, the technique of FIG. 4 includes introducing balloon14 into vasculature of a patient (42). For example, distal tip 16 ofelongated member 12 may be introduced at an incision or body opening andinto the vasculature, followed by the shaft of elongated member 12carrying balloon 14. In some examples, introducing balloon 14 into thevasculature (42) may include advancing balloon 14 carried on elongatedmember 12 over a guidewire or other guide member through the vasculatureto a target site within the vasculature. In examples in which balloon 14includes radiopaque marker 17, a clinician may use radiopaque marker 17to visualize the position of balloon 14 a relative to the target sitewithin the vasculature, for example, by radioimaging. In anotherexample, inflating balloon 14 to the predetermined pressure (40) may beperformed after introducing balloon 14 into the vasculature (42).

After balloon 14 arrives at the target site, balloon 14 may be inflated,such as by pressurizing the balloon to an operational pressure (44). Theoperational pressure may be a pressure sufficient to expand balloon 14to an operational dimension, for example, an operational diameter. Forexample, the operational diameter may be an average diameter of balloon14 in an inflated configuration that is sufficient to expand, clear, orscaffold a region of the vasculature adjacent the target site. In someexamples, the operational diameter may be a diameter sufficient todeploy second medical device 26 at the target size, for example, bycausing second medical device 26 to expand, move, or decouple fromballoon 14 or elongated member 12, and occupy the target site. In someexamples, the operational pressure may be more, less, or the same as thepredetermined pressure. In another example, balloon 14 may not beinflated to the predetermined pressure (40) prior to introducing balloon14 into vasculature of a patient (42). Rather, pressurizing the balloonto an operational pressure (44) may sufficiently rupture thenon-compliant layer of middle layer 34.

In some examples, the technique of FIG. 4 includes, after thepressurizing (44), deflating balloon 14 (46). A clinician may, forexample, withdraw inflating fluid from inflating lumen port 22 to causeballoon 14 to depressurize and contract, shrink, collapse, fold, orotherwise attain a compact configuration allowing safe withdrawal ofballoon 14 a from the vasculature. After deflating balloon 14 (46), theclinician may withdraw balloon 14 from the vasculature (48). Forexample, elongated member 12 carrying balloon 14 may be withdrawn fromthe vasculature.

While the example technique of FIG. 4 is described with respect to thevasculature, the example technique of FIG. 4 may be used to advance anddeploy balloon 14 at a target site within any body lumen accessiblethrough a body opening or incision. Thus, an example technique for usingballoon 14 has been described with reference to FIG. 4.

Example techniques for manufacturing or preparing balloon 14 aredescribed with reference to FIG. 5, which is a flowchart illustrating anexample technique for manufacturing balloon 14. In some examples, thetechnique of FIG. 5 may include coextruding a non-compliant layer oninner layer 36 (50), and coextruding outer layer 36 on the non-compliantlayer (52). As described with reference to FIGS. 3A-3D, in someexamples, middle layer 34 includes the non-compliant layer. In someexamples, inner layer 36, middle layer 34 including the non-compliantlayer, and outer layer 32 are coextruded simultaneously. For example,respective heated, flowable, or molten compositions for inner layer 36,middle layer 34, and outer layer 32 may be coextruded from an extrusiondie onto a substrate, for example, a mandrel. As described elsewhere inthe disclosure, coextrusion of the different layers may be used toobtain a nested configuration of balloons without requiring a nestingstep. A nesting step including nesting individual balloons may introducefluid or air pockets or other nonuniformities in the balloon structure.In contrast, coextrusion of multiple layers results in a uniform balloonstructure. In some examples, the technique of FIG. 5 may includecoextruding a tubing including inner layer 36, middle layer 34 includingthe non-compliant layer, and outer layer 32.

In other examples, inner layer 36, middle layer 34, and outer layer 32may be coextruded as a multilayer sheet, for example, by coextrudingonto a flat substrate. In some examples, inner layer 36, middle layer 34including the non-compliant layer, and outer layer 32 may besequentially extruded. In some examples, a pair of layers may becoextruded, followed by extrusion of another layer. For example, middlelayer 34 and inner layer 36 may be coextruded, followed by extrusion ofouter layer 32 on the coextruded structure. In some examples, middlelayer 34 and outer layer 32 may be coextruded, followed by extrusion ofinner layer 36 on the coextruded structure. In some examples, the orderof layers during extrusion or coextrusion may be different from theorder of layers in balloon 14. For example, when balloon 14 includesthree or more layers, pairs or groups of layers may be coextruded, andreordered, stacked or otherwise combined in a mold followed bypressurizing in the mold to eventually form balloon 14.

In some examples, the extrusion or coextrusion die for middle layer 34may be configured to extrude middle layer 34 defining at least one of adiscontinuity, a perforation, a window, or an opening. In some examples,the discontinuity, the perforation, the window, or the opening may bestamped, cut, or otherwise formed in middle layer 34 after extrusion orcoextrusion of middle layer 34, and before middle layer 34 is eventuallyassembled into the multilayer wall 15 a of balloon 14 a.

Balloon 14 may be formed from the multilayer tube or sheet includinginner layer 36, middle layer 34 including the non-compliant layer, andouter layer 32 (54). For example, the multilayer tube or sheet may beplaced in a mold configured to provide the shape of the balloon, and maybe expanded to occupy the periphery of the mold before the tube or sheethas cooled or otherwise cured or solidified. In some examples, therespective compositions for inner layer 36, middle layer 34 includingthe non-compliant layer, and outer layer 32 may be directly coextrudedinto the mold, so that balloon 14 is shaped during coextrusion. In someexamples, one or more of inner layer 36, middle layer 34, and outerlayer 32 may be extruded onto a reinforcing substrate, for example, areinforcing fabric, an or an arrangement of reinforcing components orfibers. In some examples, reinforcing components may be introducingduring the coextrusion.

The coextruding (50 and 52) may include stretching balloon 14. Forexample, a region or side of balloon 14 may be intermittently heated orstretched during or after the coextruding. In some examples, thestretching may include double stretching, or stretching balloon 14 fromtwo sides. In some examples, the stretching may include a primarystretching at a first pressure followed by a secondary stretching at asecond pressure. The stretching may promote a uniform wall thickness andpromote uniform inflation of balloon 14.

In some examples, the technique of FIG. 5 includes heat-setting balloon14 (56). In some examples, heat-setting may include annealing, forexample, heating and maintaining balloon 14 at a predeterminedtemperature for a predetermined period of time. The predeterminedtemperature may be near or above a melt transition of one or more oflayers 32, 34, or 36, or near or above a glass transition temperature ofone or more polymers in layers 32, 34, or 36. Heat-setting may removecreases, wrinkles, or marks from surfaces of balloon 14, and may furtherprovide a uniform thickness to a wall of balloon 14, for example, wall15 a of balloon 14 a. For example, heat-setting may also be used tocontrol the wall thickness of wall 15 a of balloon 14 a. Heat-settingmay be performed using any suitable technique. For example, balloon 14may be heated in the mold, such that the heat-setting may provide apermanent set or shape for balloon 14. Heat-setting may be used tocontrol compliance of one or more of layers 32, 34, or 36, or overallcompliance and burst resistance of balloon 14. In some examples, theconfiguration of balloon 14 as molded and heat-set may correspond to anuninflated configuration of balloon 14. In some examples, theconfiguration of balloon 14 as molded and heat-set may correspond to aninflated configuration of balloon 14.

In some examples, the technique of FIG. 5 may include inflating balloon14 to a predetermined pressure sufficient to rupture middle layer 34including the non-compliant layer (58). The predetermined pressure isinsufficient to rupture both inner layer 36 and outer layer 32. Forexample, inflating balloon 14 to the predetermined pressure may resultin formation of structures corresponding to balloons 14 a, 14 b, 14 c,or 14 d as described with reference to FIGS. 3A-3D. In some examples,the technique of FIG. 5 may include inflating balloon 14 to allow onlythe non-compliant layer to fragment at the predetermined pressure tocause inner surface 32 b defined by outer layer 32 to contact outersurface 36 a defined by inner layer 36.

In some examples, inflating balloon 14 to the predetermined pressure(58) may result in delamination of one or both of outer layer 32 frommiddle layer 34 or of middle layer 34 from inner layer 36. For example,outer layer 32 may delaminate from middle layer 34, or middle layer 34may delaminate from inner layer 36, during the inflating (58). In someexamples, at least partial delamination may occur before the rupture ofmiddle layer 34. For example, at least a portion of one of outer layer32, middle layer 34, and inner layer 36 may separate from a portion ofanother of outer layer 32, middle layer 34, and inner layer 36, beforethe rupture of any portion of middle layer 34. In some examples,complete delamination may occur before the rupture of middle layer 34.For example, outer layer 32 may completely delaminate from middle layer34, and middle layer 34 may completely delaminate from inner layer 36,before the rupture of any portion of middle layer 34. In other examples,delamination may overlap with rupture during the inflating (58). Forexample, at least a portion of one of outer layer 32, middle layer 34,and inner layer 36 may separate from a portion of another of outer layer32, middle layer 34, and inner layer 36 during rupture of a portion ofmiddle layer 32.

While forming balloon 14 (54) may precede inflating balloon 14 (58) asshown in the example of FIG. 5. In other examples, balloon 14 may beinflated to the predetermined pressure sufficient to rupturenon-compliant middle layer 34 during forming balloon 14 (54). Thus, oneor both of delamination or rupture of non-compliant middle layer 34 mayoccur during forming balloon 14 (54), and the example technique may notinclude an additional or separate inflation of balloon 14 to thepredetermined pressure sufficient to rupture balloon 14 (58).

In some examples, the technique of FIG. 5 may further include securingsecond medical device 26 to balloon 14 (60). For example, when secondmedical device 26 includes a stent, securing second medical device 26 tothe balloon (60) may include crimping the stent to balloon 14.

In some examples, the technique of FIG. 5 may further include mountingballoon 14 to elongated member 12 (62). For example, elongated member 12may include a catheter body, and balloon 14 may be mounted to thecatheter body.

Other techniques for forming balloon 14 may be used in other examples.

Various examples have been described. These and other examples arewithin the scope of the following claims.

What is claimed is:
 1. A medical device comprising: a balloon inflatable to an inflated configuration, the balloon comprising: a non-compliant layer coextruded on an inner layer; and an outer layer coextruded on the non-compliant layer, wherein the non-compliant layer is configured to delaminate from the inner and the outer layers in the inflated configuration.
 2. The medical device of claim 1, wherein the non-compliant layer is configured to delaminate from the inner layer before delaminating from the outer layer.
 3. The medical device of claim 1, wherein the non-compliant layer is configured to delaminate from the outer layer before delaminating from the inner layer.
 4. The medical device of claim 1, wherein the inner layer and the outer layers are more flexible than the non-compliant layer.
 5. The medical device of claim 1, wherein the non-compliant layer is configured to rupture in the inflated configuration at a predetermined pressure, wherein the predetermined pressure is insufficient to rupture both the inner and the outer layers.
 6. The medical device of claim 5, wherein the non-compliant layer is configured to rupture after delamination of the non-compliant layer from the inner and outer layers.
 7. The medical device of claim 5, wherein the non-compliant layer is configured to fragment in the inflated configuration at the predetermined pressure.
 8. The medical device of claim 7, wherein an inner surface defined by the outer layer is configured to contact an outer surface defined by the inner layer in the inflated configuration.
 9. The medical device of claim 8, wherein the inner layer defines an inner balloon and the outer layer defines an outer balloon, the inner balloon being nested in the outer balloon.
 10. The medical device of claim 9, wherein the inner balloon is fluidically isolated from the outer balloon.
 11. The medical device of claim 1, wherein the non-compliant layer has a greater stiffness than each of the inner layer and the outer layer.
 12. The medical device of claim 1, wherein the non-compliant layer comprises a thermoplastic.
 13. The medical device of claim 12, wherein the thermoplastic comprises a high-density polyethylene (HDPE).
 14. The medical device of claim 1, wherein one or both of the inner layer and the outer layer comprises a thermoplastic elastomer.
 15. The medical device of claim 14, wherein the thermoplastic elastomer comprises a polyether block amide (PEBA).
 16. The medical device of claim 1, wherein the non-compliant layer is coextensive with one or both of the inner layer and the outer layer.
 17. The medical device of claim 1, wherein the non-compliant layer defines at least one of a discontinuity, a perforation, a window, or an opening in the inflated configuration.
 18. A medical device comprising: a balloon inflatable to an inflated configuration, the balloon comprising: a non-compliant layer coextruded on an inner layer; and an outer layer coextruded on the non-compliant layer, wherein the non-compliant layer is configured to rupture in the inflated configuration at a predetermined pressure, wherein the predetermined pressure is insufficient to rupture both the inner and the outer layers.
 19. The medical device of claim 18, wherein the non-compliant layer is configured to delaminate from the inner and the outer layers before the rupture.
 20. The medical device of claim 18, wherein the non-compliant layer has a greater stiffness than each of the inner layer and the outer layer.
 21. The medical device of claim 18, wherein the balloon is in the inflated configuration at the predetermined pressure, and wherein the non-compliant is substantially disintegrated such that an inner surface defined by the outer layer substantially uniformly contacts an outer surface defined by the inner layer.
 22. The medical device of claim 18, wherein the non-compliant layer defines at least one of a discontinuity, a perforation, a window, or an opening in the inflated configuration.
 23. A method comprising: inflating a balloon to a predetermined pressure, wherein the balloon comprises a non-compliant layer coextruded on an inner layer and an outer layer coextruded on the non-compliant layer, wherein the predetermined pressure is sufficient to rupture the non-compliant layer and insufficient to rupture both the inner and the outer layers; deflating the balloon; and introducing the balloon into vasculature of a patient.
 24. The method of claim 23, wherein inflating the balloon at the predetermined pressure comprises causing only the non-compliant layer to rupture to cause an inner surface defined by the outer layer to contact an outer surface defined by the inner layer.
 25. The method of claim 23, wherein inflating the balloon at the predetermined pressure comprises causing only the non-compliant layer to rupture to cause the non-compliant layer to define at least one of a discontinuity, a perforation, a window, or an opening in the inflated configuration.
 26. A method comprising: inflating a balloon to a predetermined pressure, wherein the balloon comprises a non-compliant layer coextruded on an inner layer and an outer layer coextruded on the non-compliant layer, wherein the predetermined pressure is sufficient to delaminate the non-compliant layer from the inner and the outer layers; deflating the balloon; and introducing the balloon into vasculature of a patient.
 27. A method comprising: coextruding a non-compliant layer on an inner layer; coextruding an outer layer on the non-compliant layer; and forming a balloon from the inner layer, the non-compliant layer, and the outer layer, wherein the non-compliant layer is configured to delaminate from the inner and the outer layers in an inflated configuration of the balloon.
 28. The method of claim 27, wherein co-extruding the non-compliant layer on the inner layer and coextruding the outer layer on the non-compliant layer comprises coextruding a tubing comprising the inner layer, the non-compliant layer, and the outer layer.
 29. The method of claim 27, wherein the forming the balloon comprises molding the inner layer, the non-compliant layer, and the outer layer over a scaffold.
 30. The method of claim 27, further comprising heat-setting the balloon.
 31. The method of claim 27, further comprising inflating the balloon to a predetermined pressure sufficient to rupture the non-compliant layer, wherein the predetermined pressure is insufficient to rupture both the inner and the outer layers.
 32. The method of claim 27, further comprising allowing only the non-compliant layer to fragment at the predetermined pressure to cause an inner surface defined by the outer layer to contact an outer surface defined by the inner layer.
 33. A method comprising: coextruding a non-compliant layer on an inner layer; coextruding an outer layer on the non-compliant layer; and forming a balloon from the inner layer, the non-compliant layer, and the outer layer, wherein only the non-compliant layer is configured to rupture in an inflated configuration of the balloon at a predetermined pressure.
 34. The method of claim 33, wherein co-extruding the non-compliant layer on the inner layer and coextruding the outer layer on the non-compliant layer comprises coextruding a tubing comprising the inner layer, the non-compliant layer, and the outer layer.
 35. The method of claim 33, further comprising inflating the balloon to the predetermined pressure to delaminate the non-compliant layer from the inner and the outer layers. 